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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00939003
Registration number
NCT00939003
Ethics application status
Date submitted
10/07/2009
Date registered
14/07/2009
Date last updated
9/09/2014
Titles & IDs
Public title
Study of Adalimumab in Patients With Axial Spondyloarthritis
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Scientific title
A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis
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Secondary ID [1]
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2009-010643-14
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Secondary ID [2]
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M10-791
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Axial Spondyloarthritis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Adalimumab
Other interventions - Placebo
Other interventions - Open-label Adalimumab
Experimental: Adalimumab -
Placebo Comparator: Placebo -
Experimental: Open-label Adalimumab -
Other interventions: Adalimumab
40 mg every other week up to Week 12
Other interventions: Placebo
Placebo every other week up to Week 12
Other interventions: Open-label Adalimumab
40 mg every other week, Week 12 through Week 156
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 40 Response
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Assessment method [1]
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ASAS40 response was defined as improvement of = 40% relative to Baseline and absolute improvement of = 20 units (on a scale from 0 to 100) in = 3 of the following 4 domains with no deterioration (defined as a net worsening of > 0 units on a scale from 0 to 100) in the potential remaining domain:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [1]
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Number of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
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Assessment method [1]
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ASAS20 response was defined as improvement of = 20% relative to Baseline and absolute improvement of = 10 units (on a scale from 0 to 100) in = 3 of the following 4 domains with no deterioration (defined as a change for the worse of = 20% and net worsening of = 10 units) in the potential remaining domain:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Number of Participants Achieving a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
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Assessment method [2]
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The Bath Ankylosing Spondylitis (AS) Disease Activity Index assesses disease activity by asking the participant to answer 6 questions (each on a 10 cm VAS) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (= 2 hours). The overall BASDAI score ranges from 0 to 10 cm. Lower scores indicate less disease activity. BASDAI50 is a 50% improvement from Baseline in BASDAI score.
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Change From Baseline in Short Form-36 (SF-36) Physical Component Summary Score
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Assessment method [3]
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The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life. The SF-36 consists of 36 questions in 8 domains (limitations in physical functioning due to health problems; limitations in usual role because of physical health problems; bodily pain; general health perceptions; vitality; limitations in social functioning because of physical or emotional problems; limitations in usual role due to emotional problems; and general mental health). Two component scores can be summarized: physical and mental; domains 1-4 comprise the physical component summary of the SF-36. A transformed summary score is calculated ranging from 0 to 100 where higher scores indicate a higher level of functioning. A positive change from Baseline score indicates an improvement.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Number of Participants Achieving ASAS Partial Remission
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Assessment method [4]
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ASAS partial remission is an absolute score of < 20 units on a 0 to 100 scale for each of the four following domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none/0 hours) to 10 (very severe/2 hours or more duration).
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Number of Participants Achieving an ASAS5/6 Response
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Assessment method [5]
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ASAS5/6 response is a 20% improvement in five out of the following six domains:
Patient's Global Assessment of disease activity, measured on a visual analog scale (VAS) from 0 (none) to 100 (severe);
Pain, measured by the total back pain VAS from 0 (no pain) to 100 (most severe);
Function, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) which consists of 10 items assessing participants' ability to perform activities on a VAS ranging from 0 (easy) to 100 (impossible);
Inflammation, measured by the mean of the 2 morning stiffness-related Bath AS Disease Activity Index (BASDAI) VAS scores (items 5 [level of stiffness] and 6 [duration of stiffness]) each on a scale from 0 (none) to 10 (very severe/2 hours or more duration).
Spinal mobility, measured from the lateral lumbar flexion score of the Bath AS Metrology Index (BASMI) on a scale from 0 (best mobility) to 10 (worst mobility);
C-reactive protein level (lower levels indicate less inflammation).
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Timepoint [5]
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Baseline and Week 12
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Secondary outcome [6]
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Change From Baseline in Disability Index of Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S)
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Assessment method [6]
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Health Assessment Questionnaire modified for spondyloarthropathies (HAQ-S) is a self-reported measure to assess the physical function and health-related quality of life. The Disability Index (DI) of HAQ-S is calculated as the mean of the following 8 category scores (range: 0 [without any difficulty] to 3 [unable to do]): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Five additional items in the functional status measure were included in the HAQ-S, including carrying heavy packages, sitting for long periods, able to work at a flat topped table, and (if the participant had a driver's license or a car) able to look in the rear view mirror and able to turn head to drive in reverse. The overall score ranges from 0 (no disability) to 3 (three very severe, high-dependency disability). Negative mean changes from Baseline in the overall score indicate improvement.
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
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Assessment method [7]
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C-reactive protein (CRP) is considered an efficacy variable for the axial spondyloarthritis indication. It is a general marker of inflammation that is sensitive to acute changes in inflammatory response. Higher levels indicate more inflammation.
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Timepoint [7]
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Baseline and Week 12
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Secondary outcome [8]
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Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Score for Sacroiliac Joints
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Assessment method [8]
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Six consecutive sacroiliac (SI) joint image coronal slices representing the largest proportion of the synovial compartment of the SI joints were assessed for edema, intensity and depth of edema using SPARCC scoring.
Each SI joint (left and right) was divided into quadrants for a total of 8 SI scoring locations. Each quadrant was scored for the presence (1) or absence (0) of edema; the maximum score is 8 per slice and maximum score for 6 SI joint slices is 48.
Intensity of edema: A score of 1 was assigned for each SI joint (left and right) if an intense signal was seen in any quadrant of that joint for each slice. The maximum score is 2 per slice and 12 for 6 slices.
A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the articular surface of the SI joint in any quadrant. The maximum score per slice is 2 and for 6 slices 12.
The total maximum score for all SI joints across 6 slices is 72.
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Timepoint [8]
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Baseline and Week 12
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Secondary outcome [9]
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Change From Baseline in SPARCC MRI Score for the Spine
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Assessment method [9]
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Six discovertebral units (DVU) representing the 6 most abnormal DVUs, and 3 consecutive sagittal slices at each DVU representing the most abnormal slices for that DVU were selected for scoring. Each DVU was divided into 4 quadrants and scored for the presence (1) or absence (0) of edema. The maximum score is 12 per DVU. The maximum score is 72 for 6 DVUs.
If edema was present in at least 1 quadrant of a DVU slice, it was scored for intensity and depth of the edema representing that slice:
A score of 1 was assigned if an intense signal was seen in any quadrant on a DVU slice. The maximum score for intensity per slice is 1, per DVU is 3 and for 6 DVUs is 18.
A lesion was graded as deep (score of 1) if there was homogeneous and unequivocal increase in signal extending over a depth of at least 1 cm from the surface of the endplate in any quadrant. The maximum score per slice is 1, for a DVU is 3 and for 6 DVUs is 18.
The total maximum SPARCC score for all 6 DVUs is 108.
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Timepoint [9]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
- Adult patients with inadequate response to >/= 1 non-steroidal anti-inflammatory drugs
(NSAIDs)
- Chronic back pain with onset < 45 years of age
- Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human
leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis
clinical criteria
- Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline
visit must be negative
- Ability to administer subcutaneous injections
- General good health otherwise
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior anti-tumor necrosis factor (TNF) therapy
- Psoriasis or psoriatic arthritis
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Recent infection requiring treatment
- Significant medical events or conditions that may put patients at risk for
participation
- Females who are pregnant or breast-feeding or considering becoming pregnant during the
study
- History of cancer, except successfully treated skin cancer
- Recent history of drug or alcohol abuse
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2013
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Sample size
Target
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Accrual to date
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Final
192
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Site Reference ID/Investigator# 22342 - Brisbane
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Recruitment hospital [2]
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Site Reference ID/Investigator# 21223 - Kogarah
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Recruitment hospital [3]
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Site Reference ID/Investigator# 21222 - Maroochydore
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4558 - Maroochydore
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Colorado
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United States of America
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Maryland
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United States of America
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Pennsylvania
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United States of America
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Texas
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Country [6]
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United States of America
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State/province [6]
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Washington
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Country [7]
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Belgium
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State/province [7]
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Genk
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Belgium
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State/province [8]
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Ghent
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Belgium
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Gilly
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Belgium
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Merksem
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Canada
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Edmonton
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Country [12]
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Canada
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State/province [12]
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Sainte-Foy, Quebec
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Canada
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State/province [13]
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St. John's
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Canada
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State/province [14]
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Toronto
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Czech Republic
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State/province [15]
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Brno
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Czech Republic
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State/province [16]
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Pardubice
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Czech Republic
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State/province [17]
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Prague 2
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Country [18]
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Czech Republic
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State/province [18]
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Uherske Hradiste
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Country [19]
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France
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Boulogne Billancourt
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France
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Chambray-les-Tour
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France
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State/province [21]
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Orleans
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France
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Paris Cedex 14
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Germany
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State/province [23]
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Berlin
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Germany
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Erlangen
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Germany
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Herne
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Germany
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Munich
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Country [27]
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Netherlands
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State/province [27]
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Amsterdam
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Netherlands
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Leiden
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Spain
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State/province [29]
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A Coruna
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Spain
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State/province [30]
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Barcelona
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Spain
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State/province [31]
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Cordoba
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Country [32]
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United Kingdom
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State/province [32]
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Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie (prior sponsor, Abbott)
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate how well adalimumab works in the short and long term in patients
with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or
psoriatic arthritis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00939003
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Aileen L Pangan, MD
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00939003
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